Medicon Valley Alliance and BioAgilytix would like to welcome you to a Good Morning Meeting.
In the realm of biotherapeutics, which include a diverse array of antibodies, proteins, hormones, enzymes and peptides, understanding and managing immunogenicity is of paramount importance. As biotherapeutic modalities increase in complexity, so too does the immunogenicity assessment strategy and the requirements for bioanalytical assays. Please join us where we will share insights on the current regulatory landscape and case studies of approaches taken with pro-drugs and multi-domain therapeutics.
Date: Tuesday 4th of June 2024
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub2 Auditorium
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | BioAgilytix introduction & updates Ymke van der Geld, Business Development Director, Scandinavia, BioAgilytix |
| 9:10 | Current regulatory landscape for immunogenicity assessment Robert Nelson, PhD, Scientific Officer, BioAgilytix |
| 9:25 | Pro-drugs: what are the challenges for ADA testing? Susanne Pihl, Msc, Director, Clinical Pharmacology & Bioanalysis, Ascendis Pharma |
| 9:45 | Application of different approaches to ADA domain specificity characterization Christopher Tiedje, Associate Director Bioanalytical Operations, BioAgilytix |
| 10:05 | Q&A Session |
| 10:30 | Networking |
| 11:00 | End of Good Morning Meeting |
Speakers
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Ymke van der Geld, PhD, Senior Director, Business Development Europe, BioAgilytix Ymke is looking after Business Development for BioAgilytix in the Nordics region. She is your point of contact for BioAgilytix Bioanalytical offering including tailored services for biomarker, immunogenicity, pharmacokinetics (PK), and cell-based assays. This includes cell- & gene therapy, monoclonal antibodies, complex bi-/tri-specific and other fusion molecule/ protein formats and Antibody Drug Conjugates. Ymke has a background in medical biology with a PhD in Immunology. Ymke has over 20 years of experience within Bioanalytical contract research. |
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Robert Nelson, PhD, Scientific Officer, BioAgilytix Robert Nelson, Ph.D., provides scientific and regulatory consultation, focusing on our EU team and customers, to help guide bioanalysis supporting drug development. Spending over fifteen years working in regulated (GLP/GCP) laboratory environments, Dr. Nelson supports preclinical and clinical drug development programs, with broad experience in bioanalysis, immunogenicity, and biomarkers. He joined BioAgilytix from Labcorp Drug Development’s Scientific Affairs team, where he partnered with clients, operations, and other scientists to address science, technology, and regulatory challenges. Prior to this, he led the bioanalytical laboratory team at Swiss biotech company Novimmune. Dr. Nelson holds his Ph.D. in Molecular Physiology and B.Sc. with Honours in Pharmacology from the University of Edinburgh. |
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Susanne Pihl, Director, Msc, Clinical Pharmacology & Bioanalysis, Ascendis Pharma Susanne Pihl has more than 20 years of experience in regulated bioanalysis. Since 2015, she has worked at Ascendis Pharma, Copenhagen, where she is responsible for the bioanalytical strategy on various drug development programs and oversees the outsourcing of bioanalysis, immunogenicity, and pharmacokinetic data analyses. Prior to this, she worked at H. Lundbeck A/S for 14 years as Primary bioanalytical scientist and pharmacokineticist. Susanne holds a MSc (engineering – chemistry) from the Technical University of Denmark and a Master of Industrial Drug Development (MIND) from the University of Copenhagen. |
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Christopher Tiedje, PhD, Associate Director Bioanalytical Operations, BioAgilytix Christopher Tiedje is Associate Director Bioanalytical Operations at BioAgilytix Europe GmbH, Hamburg where he oversees the conduct of pharmacokinetic, immunogenicity and biomarker bioanalytical assay establishment, validation and sample analysis in support of sponsors’ drug development program. Chris obtained his Diploma degree in Biochemistry from the Leibniz Universität, Hannover, then undertook a PhD in Biochemistry and Molecular Biology at Kiel University (CAU). Before joining BioAgilytix in early 2020, Chris had a distinguish academic career with post-doctoral positions at Hannover Medical School and the Babraham Institute, Cambridge, and an Associate Professorship at Københavns Universitet, Copenhagen. |
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